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Pfizer will submit a NDA with FDA for palbociclib, a treatment for locally advanced or metastatic breast cancer.
Pfizer reported that it will submit a new drug application (NDA) with FDA for palbociclib, combined with letrozole, as first-line systemic treatment of post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Pfizer expects to submit the NDA early in the third quarter of this year. This decision was based on discussions with FDA regarding the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.
Palbociclib received breakthrough therapy designation from FDA in April 2013.